ACTRN12618000842268已完成未知
The Postpartum Sleep Study for Mothers (The POSSUM Project): A randomised controlled trial of interventions to improve sleep and wellbeing in sleep-disturbed first-time mothers.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Inclusion criteria include (a) first-time mothers between four to twelve months postpartum; (b) aged 18 years or above; (c) singleton pregnancy; (d) ability to read and write in English; (e) regular access to phone, email and internet.
排除标准
- •Exclusion Criteria:
- •Currently pregnant.
- •Fixed night shiftwork between midnight and 5am, or rotating work schedules that require night shifts during project participation.
- •Insomnia Severity Index score of <8 at baseline.
- •Participants who show the following current symptoms of sleep disorders as (assessed using the Duke Structured Interview for Sleep Disorders; Edinger et al., 2009):
- •Sleep apnea: loud snoring OR observed gasping or pauses in breathing OR previously diagnosed with apnea hypopnea index >15 but not/inadequately treated.
- •Previously diagnosed Periodic Limb Movement Disorder with arousal index >15 and currently untreated.
- •Untreated Restless Legs Syndrome (RLS) occurring 3 times/week, with duration of at least one month.
- •Current circadian rhythm disorders including:
- •Irregular Sleep Wake Disorder.
- •Non-24-Hour Sleep-Wake Syndrome.
- •Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8pm and habitual wake time is earlier than 4am. Occasional deviation from this schedule is allowed).
- •Narcolepsy
- •Have unstable medical conditions that directly affect sleep.
- •Take medication that affects sleep (including sleep medications, melatonin, steroid inhalers, antidepressant medications, cannabis, etc.).
- •Report current Post-traumatic Stress Disorder, Panic Disorder (if > 4 times nocturnal in the past month), Bipolar Disorder, Psychotic disorders or Substance Use Disorders. Exclusion of those with current depression will only occur if risk issues are evident assessed during initial telephone interview – those with current suicidal ideation/self-harm behaviours or who pose a risk of harm to others will be excluded and referred to appropriate services.
- •Have infants with medical conditions that affect sleep.
- •Have been advised be health professionals to avoid exposure to bright light (including chronic migraines and eye conditions such as macular degeneration, eye diseases).
- •Expresses personal preference or concerns regarding exposure to bright light.
- •Suffer from epilepsy.
- •Reports on average, 3 or more infant awakenings per night over the past month requiring parental assistance to reinitiate sleep
- •- Participants who pose a risk of harm to either themselves or to others will be excluded (assessed in a risk assessment during the telephone screening interview at baseline).
研究者
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